The Effect of a Honey-based Gel Supplement From the Wider Area of Pindos on Human Health and Oxidative Stress Biomarkers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Thessaly
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Change in glutathione concentration of erythrocytes
Study Overview
Brief Summary
The aim of the present clinical study is to estimate the efficacy of a honey-based gel, derived from the wider area of Pindos in Greece, in regulating oxidative stress biomarkers and the physiological profile of healthy adults.
Detailed Description
Introduction
Honey contains about 200 compounds such as sugars, proteins, vitamins, water, free amino acids, enzymes, minerals, and many phytochemicals. Due to its composition, enriched with many bioactive ingredients, several studies have established its antimicrobial, antiviral, anticancer, antidiabetic and antioxidant properties. This multilayer activity of honey has been proposed for the protection against pathologies interrelated with the cardiovascular, nervous, respiratory, and gastrointestinal system.
Purpose: This study aims to investigate the effects of a novel natural honey-based gel consumption on oxidative stress biomarkers, blood chemistry and physiological characteristics in healthy individuals.
Methodology: A total of 20 healthy men and women will participate in the study. Participants will give their informed consent after they will be informed about the purposes, procedures, risks and benefits associated with the study. Participants will consume 70 g/day of the honey-based gel, distributed in 2 equal doses (in the morning and evening) for 14 days. At baseline and post-intervention, volunteers will be assessed for their physiological profile and will provide a resting blood sample for the assessment of oxidative stress and blood chemistry biomarkers as well as their physiological profile. Participants will be asked to record their diet for 3 days prior to the study and they will be asked to follow the same dietary pattern for 3 days before the post-intervention assessments.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy Individuals aged 18-65 years
- •Non-smokers
Exclusion Criteria
- •Musculoskeletal injury
- •Dietary supplements
- •Medication
- •Allergy in bee pollen
Outcomes
Primary Outcomes
Change in glutathione concentration of erythrocytes
Time Frame: Change from baseline to 14 days
Glutathione concentration will be analyzed in erythrocytes by spectrophotometry
Change in total antioxidant capacity of plasma
Time Frame: Change from baseline to 14 days
Total antioxidant capacity will be analyzed in plasma by spectrophotometry
Change in protein carbonyls of plasma
Time Frame: Change from baseline to 14 days
Protein Carbonyls will be analyzed in plasma by spectrophotometry
Change in thiobarbituric acid reactive substances of plasma
Time Frame: Change from baseline to 14 days
Thiobarbituric acid reactive substances will be analyzed in plasma by spectrophotometry
Change in body weight
Time Frame: Change from baseline to 14 days
Body weight will be measured using a digital scale
Change in catalase enzyme activity of erythrocytes
Time Frame: Change from baseline to 14 days
Catalase enzyme activity will be analyzed in erythrocytes by spectrophotometry
Change in complete blood count
Time Frame: Change from baseline to 14 days
White blood cells, lymphocytes, monocytes, granulocytes, red blood cells and platelets will be analyzed in whole blood
Change in body fat
Time Frame: Change from baseline to 14 days
Body fat will be measured by bioelectrical impedance analysis
Change in diastolic and systolic blood pressure
Time Frame: Change from baseline to 14 days
Diastolic and systolic blood pressure will be measured using a manual sphygmomanometer
Change in waist and hip circumference
Time Frame: Change from baseline to 14 days
Waist and hip circumference will be assessed using a tape measure
Change in resting heart rate
Time Frame: Change from baseline to 14 days
Resting heart rate will be measured using a heart rate sensor
Secondary Outcomes
No secondary outcomes reported
Investigators
Athanasios Z. Jamurtas
Professor
University of Thessaly